Baclofen
- Product NDC
- 63187-313
- 11-digit product format
- 631870313
- Labeler code
- 63187
- Product ID
- 63187-313_83a0b967-118f-4459-ad38-1ec6a769dcc4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- baclofen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA077241
- Marketing category
- ANDA
- Marketing start
- 2005-12-01
- Substance
- BACLOFEN
- Active strength
- 10 mg/1
- Pharmacologic classes
- GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Baclofen
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BACLOFEN | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | H789N3FKE8 |
| Rxcui | 197391, 197392 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-313-20 | Baclofen | 20 in 1 BOTTLE, PLASTIC | TABLET | 20 | | 8 |
| 63187-313-30 | Baclofen | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 8 |
| 63187-313-60 | Baclofen | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 8 |
| 63187-313-72 | Baclofen | 120 in 1 BOTTLE, PLASTIC | TABLET | 120 | | 8 |
| 63187-313-78 | Baclofen | 180 in 1 BOTTLE, PLASTIC | TABLET | 180 | | 8 |
| 63187-313-90 | Baclofen | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 8 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-313 | BACLOFEN TABLET [PROFICIENT RX LP] | 8 | Current NDC, Legacy NDC, 6 package rows | 20200505_924a01fb-0ed0-4f73-9304-d6c5b9961d66.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63187-313-20 | 63187031320 | 20 TABLET in 1 BOTTLE, PLASTIC (63187-313-20) | 20 tablet | 2018-10-01 | 0000-00-00 | No | No | Current |
| 63187-313-30 | 63187031330 | 30 TABLET in 1 BOTTLE, PLASTIC (63187-313-30) | 30 tablet | 2014-05-01 | 0000-00-00 | No | No | Current |
| 63187-313-60 | 63187031360 | 60 TABLET in 1 BOTTLE, PLASTIC (63187-313-60) | 60 tablet | 2014-05-01 | 0000-00-00 | No | No | Current |
| 63187-313-72 | 63187031372 | 120 TABLET in 1 BOTTLE, PLASTIC (63187-313-72) | 120 tablet | 2017-03-01 | 0000-00-00 | No | No | Current |
| 63187-313-78 | 63187031378 | 180 TABLET in 1 BOTTLE, PLASTIC (63187-313-78) | 180 tablet | 2018-03-01 | 0000-00-00 | No | No | Current |
| 63187-313-90 | 63187031390 | 90 TABLET in 1 BOTTLE, PLASTIC (63187-313-90) | 90 tablet | 2014-05-01 | 0000-00-00 | No | No | Current |